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Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- June 29 to August 31, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across to alpha amylase is applied. Data on alpha amylase are considered also to be valid for beta-mannosidase, because both enzymes belong to the same enzyme sub-subclass IUB 3.2.1 and are considered to have a similar toxicological profile also with regard to acute toxicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Dec. 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Active enzyme protein of alpha-amylase (EC no. 232-565-6, CAS no. 9000-90-2, EC name: Amylase, alpha-, Enzyme Class No.: 3.2.1.1)
- Molecular formula:
- Not available
- IUPAC Name:
- Active enzyme protein of alpha-amylase (EC no. 232-565-6, CAS no. 9000-90-2, EC name: Amylase, alpha-, Enzyme Class No.: 3.2.1.1)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- - Lot/batch No.: PPY 31071
- Expiration date of the lot/batch: 1 June 2020
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River, Germany
- Fasting period before dosing: Overnight
- Housing: A maximum of 6 animals per sex per cage, transparent macrolon cages
- Weight at time of dosing: between 168-174 g
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Tap water ad libitum
- Acclimatization period: 5 days
- Temperature (°C): 20-24°C
- Humidity : 45-70 %
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
- Doses:
- Undiluted test material 20 mL/kg body weight, equivalent to 2562 mg enzyme concentrate dry matter/kg body weight or 859 mg aep/kg body weight (limit testing).
- No. of animals per sex per dose:
- 6 (only females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs of effect: within 1 hour and within 4 hours after dosing and at least once daily throughout the observation period. Weighing: just prior to dosing on day 0 and on days 3, 7 and 14
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 562 mg/kg bw
- Based on:
- other: Enzyme concentrate dry matter
- Sex:
- female
- Dose descriptor:
- other: Limit test - no effects were seen
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality.
- Clinical signs:
- other: No clinical signs.
- Gross pathology:
- No abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of toxicity were observed among the rats treated with a single oral dose of 2562 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 859 mg aep/kg bodyweight), which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item.
- Executive summary:
The objective of this study was to assess the acute toxicity of alpha-amylase when administered as a single oral dose to rats followed by an observation period of 14 days. The purpose of the study was to satisfy regulatory demands because the enzyme is used for production of food in EU.
The study was conducted in accordance with the OECD Guideline No 423, “Acute Oral Toxicity – Acute Toxic Class method”. The design of the limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 20 mL/kg body weight corresponding to a dose of 2562 mg enzyme concentrate dry matter/kg body weight (equivalent to 859 mg aep/kg body weight). This was the highest possible dose level at dose volume 20 mL/kg body weight, using the undiluted test item.
No mortality or clinical signs were observed after treatment and the overall body weight gain during the study was considered to be normal. The necropsy revealed no abnormalities.
In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2562 mg enzyme concentrate dry matter/kg body weight, which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item.
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